COMPOSITE ORTHODONTIC BRACKETS
FDA 510(k) clearance K140807 · decided 2014-11-12
Clearance details
- K-number
- K140807
- Device name
- COMPOSITE ORTHODONTIC BRACKETS
- Applicant
- Ortho Specialties
- Decision
- Substantially Equivalent
- Date received
- 2014-04-01
- Decision date
- 2014-11-12
- Days to decision
- 225 days
- Clearance type
- Traditional
- Product code
- DYW
- Device class
- 2
- Regulation number
- 872.5470
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Gurnee, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Carriere® Motion Pro® Clear Bite Corrector (K252760) | Ortho Organizers, Inc. | 2025-11-27 |
| Composite Orthodontic Brackets and Buttons (K251196) | Ec Certification Service GmbH | 2025-04-21 |
| Braces on Demand Bracket (K201940) | Braces on Demand, Inc. | 2020-12-03 |
| Blue Sky Bio Computerized Orthodontic Bracket System (K182338) | Blue Sky Bio | 2018-11-09 |
| ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES (K180718) | Tomy, Inc. | 2018-10-30 |
| Carriere Motion Clear Class II (K160720) | Ortho Organizers, Inc. | 2016-11-28 |
| CompleClear Plastic Orthodontic Bracket and Wire Appliance (K150830) | Oracrew | 2016-08-26 |
| Exceed Tx (K150702) | Great Lakes Orthodontics, Ltd. | 2016-03-24 |
| INSIGNIA DIGICAST (K123118) | Ormco Corp. | 2013-03-26 |
| INSIGNIA WITH ITERO (K123416) | Ormco Corp. | 2013-03-13 |
| INSIGNIA (K121524) | Ormco Corp. | 2012-08-09 |
| SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE (K110796) | Biomers Products, LLC | 2011-03-31 |
Recalls involving this device
No recalls on record reference this clearance.